`By: Dianne B. Elderkin (delderkin@akingump.com)
` Steven D. Maslowski (smaslowski@akingump.com)
` AKIN GUMP STRAUSS HAUER & FELD LLP
` Two Commerce Square
` 2001 Market Street, Suite 4100
` Philadelphia, PA 19103
` Tel: (215) 965-1200
` Fax: (215) 965-1210
`
` Paper No. ___
` Date Filed: May 12, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`PHARMATECH SOLUTIONS, INC.
`Petitioner
`
`v.
`
`LIFESCAN SCOTLAND LTD.
`Patent Owner
`________________
`
`Case IPR2013-00247
`Patent 7,250,105
`________________
`
`
`
`PATENT OWNER’S DEMONSTRATIVE EXHIBITS
`
`
`
`
`
`
`
`
`
`
`
`
`PHARMATECH SOLUTIONS, INC.
`Petitioner
`v.
`LIFESCAN SCOTLAND LTD.
`Patent Owner
`
`Case IPR2013-00247
`Patent 7,250,105
`
`LifeScan Scotland Ltd.’s Demonstrative Slides
`
`11111
`
`
`
`(12; United St3tBS Patent
`Davies et al.
`
`(10) Patent NIL:
`(45) Date of Patent:
`
`US 7,250,105 B1
`"'Jnl. 31, 2007
`
`1. A method tifineasttriiig the concentration of a substance
`in a sample liquid comprising the steps of:
`providin a measurin device said device cont risin :
`Fo
`
`in die sant
`
`first Wflfi-Lil]
`
`dovvnstreani. liorn said
`
`in the sample liquid vvherein said first and
`second workillg sensor parts are arranged such that.
`in the absence ol’ an error condition. tl1e quantity-' of
`said charge carriers generated by said first worlting
`sensors part are substantially identical to the qttantitjv
`
`of said charge earriers generated by said secortcl :
`wmking 5m.lSL.”. pan: and
`W 1tt.lt reli-.re11ee sensor
`part is a t:tZIlIJ.I'l'1tJt‘t retierenee for both the first and
`second vvorking sensor parts. said reference sensor
`part and said first and second vvorl-:ing sensor parts
`being arranged such that the sample liquid is cons
`strained to flow snlsistantially unidirectiona|]}= across
`2
`said reference sensor part and said lirsl and second
`working sensor parts: vvherein said lirst and second
`vvorldng sensor parts and said reference sensor part
`are provided on a disposable test strip:
`
`
`
`(12; United States Patent
`Davies et al
`
`(10; Patent No:
`(45) Date of Patent:
`
`US 7,250,105 B1
`*Jul. 31, 2007
`
`appi}*ing'll1e sanlplc liquid in said n1e:—1sur:1ng device;
`measuring an electric current at each wurking, scxlsur purl
`pmpnrtinnal In the ::nnccntr:.nim1 of said substance in
`the 5:-unplr.-: iiuuid;
`
`3
`
`
`
`Measuring Device
`
`Measuring/Comparing/Error
`
`OR
`
`Ex. 1003
`
`Ex. 1005
`
`4
`
`Ex. 1007
`
`
`
`Reasons Why Combinations of
`References Do Not Disclose All Claimed
`Elements
`
`5
`
`
`
`lllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllilllllllllll
`
`USDDSIZEHZUA
`[an Patent Number:
`[451 Date of Patent:
`
`5,120,420
`Jun. 9, 1992
`
`.... .. dlfiflfifl
`4,413,143 1331933 flbcrhardl ................
`4,545,332 lflr’l9‘35 Higgins El 3].
`.................... .. 435z’IE{}
`4.391103
`1:19:00 hiankai El :1].
`..................... .. 2043412
`4.900.405
`2:19sr0 fllagawa at a].
`............... 204,053.15
`
`FOREIGN PATENT DOCUMENTS
`52.131559 M1931 Japan .................................... .. zme.
`I53-3245 H1933 Japan
`21x36
`as-53149 mass Japan ...................................... 2:020
`Prfmarjr Exarm'm3r—John Niebling
`Assistant Examfner—Bruce F. Bell
`Attorney. Agent. or Ffrm—St-wens, Davis, Miller at
`""°"""
`1'-—.i
`
`6
`
`Ex. 1003
`
`.
`
`.
`
`[54] BIDSENSDR AND A PROCESS FDR
`PR]-:P_a,]u,,']"][},N; THEREQF
`‘
`_
`Inventors: Shim hankai, I-Ilrakata; Marika
`Knwnguri; Mnyumi Ohtani, both of
`Moriguchj; Takashi Iijima, Hirakala,
`all-of Japan
`.
`:’:::“‘g:i:EJl:;';;‘ 1""“5“"" 5°"
`“E632
`Mar. 31, 1939
`PCD'JPs9r00331
`
`.
`Umted States Patent
`Nani-zai at al.
`
`[191
`
`.
`
`_
`
`‘°‘55'5"°‘*'
`,
`[2]] AFPL ND"
`[22] PCT Filed:
`[35] PCT No.:
`
`
`
`a reference sensor part upstream from said. first and
`second. working sensor parts ‘
`
`20.
`
`Na11kai (‘420) discloses a test strip (or “measuring device”) that includes
`
`all of the features of the measuring device of claim 1, except it does not explicitly
`
`place the reference sensor upstream of the working sensor parts, as set forth in the
`Ex. 1024 Declaration of Joseph Wang
`
`claim chart below-
`
`Ex. 1024 Declaration ofJoseph Wang
`
`7
`
`
`
`a reference sensor part upstream from said first and
`second Working sensor parts a
`
`I disagree that “there is no criticalitjr in
`
`arranging t:I1e reference electrode upstream," as argued by Pharmatnech Since t:I1e
`
`reference electrode in Nan]-:ai is placed downstream of the working electrodes,
`
`when insufficient blood is applied, the electrode that would be i.t£I£{2I:EIIIp.l.E‘lE.ljV
`
`covered would be the reference electrode rather than a working electrode.
`
`Coverage of a minor portion of the refenence electrode could cause a higher than
`
`oormalcurrentdensitjrtoflowinthecoveredpartofflaeelectrode, alteringthe
`
`ability of the reference electrode to prcrvide a stable potential agaimt which the
`
`Working electrode could be established and pfl‘l'£IlI2ifi.l.l'jF causing inaccurate
`
`measurements of glucose- Nanlcai would not detect an inaccurate measurement:
`
`made at any one of, or all of, the working electrodes; it would merely average the
`
`Ex. 2008 Declaration of John L. Smith
`
`inaccurate n1easuren:1ent(s)_ Nankai does not recognize t:he criticality of placing the
`8
`reference electrode upstrearn from the working electrode fin ohtaining accurate
`
`measurements.
`
`
`
`(12; United States Patent
`Winarta at al.
`
`(10) Patent NIL:
`
`(45) Date of Patent:
`
`US 6,253,229 B1
`Jul. 10, 20-01
`
`USU06258229E1
`
`(54) DISPUSABLE SIJH-MICRULITER VUILUME
`SENSOR AND METHOD OF MAKING
`
`Inventors: Handani Winarta, 18 Hyacinth Dr,
`Nashua, NH {US} E|'3{}tEi2; Xianhuau Cai,
`19 Mcflulloch SL, Hectlham, MA (US)
`D2494; Fung Sam, 31 Pratt D11,
`Newton, MA {US} U246-5; Chung
`Chang Young, 145 Buckskin Dr.,
`Weston, MA (US) [|2|'§-'3
`
`4,."l9':J'Ifr Hill et al. .
`5,5'L}‘£|_.41L|
`5,515-3,06? * 11'J,e'l99I3 Sugiltnra at al.
`5,623,890
`5.-’ 1997 Carter at al. .
`5,fiTD,fl31 *
`*;I,.’19';rT
`Ilintachc at al.
`
`$182,384
`5,’.='DS_.24'r'
`
`5,'.='55_,'§I53
`5.?S9_.3r34
`5,'t'fi2,T?tI
`fi?t'H'}4_.44l
`
`1131997 Hill at al. .
`1.-’ 1998 ]'v.[c:A]t:t:r at al. .
`
`5.-’ 1998 Hetming at al. .
`E1998 Charlton at al.
`.
`fi,=“lQQfi Pritchard et a].
`* l2,."lfJ'2t'2I Fujiwara etal.
`
`.
`
`OTI II".-R PUBLICATIONS
`
`9
`
`Ex. 1005
`
`
`
`a second working sensor part downstream from said
`first working sensor part also for generating charge
`carriers in progortion to the concentration of said
`substance in the sample liguid wherein said first and
`
`10
`
`
`
`TIiaJ:+i_l.u:.pIx:.gcrs'
`Tel: S71-3??-TI'313
`
`Paper 11
`Entered; _-5.ugu..'1'1i ID13-
`
`L'N1TED STATES P.'i't1'F_"*I'1' _-5LI~TEl
`
`'1'R..'1'uDE?eL|'-'LRK GFFICE
`
`BEF'0'REfl{EI'A'IENTTElALA1~JDfi.PPEALBOARD
`
`PHARM_-'-'L'I'ECI'I SUl.U'l'ION5. INC.
`P'H:i.I:i.ou:IEr
`
`1.‘.
`
`LIIEECAN 5CC|"l'LAI~3lD LTD.
`Patent C|'wner
`
`C .152 IPFS-D13--{||}24'.'
`Patent TI'_.35|3|.1'|I|5
`
`E-efinre S.’-".lJ_".‘t' C. 7.‘-f|E}LEY. SCDTI R BOAHCK and SCDTI E. K.-5..MI'IDI_Z.
`.-I::7rr1:'?rr'.rrr'a'ri1'e.F"ater11'.Tudge.':
`
`K..'5'uI'-'I|I'IU.LZ. _»-1.r:‘i1I.Iirrf;1?'an"ra' Paremr Judge.
`
`DECISICIN
`InsI:it'I:I.ti.o:I:L offieter Pa7'I£:: Resign’
`.1‘-F CIR. 57 4'2 .i'[}.'i‘
`
`Regardj11gli1ujtatieu(a), we agree with Pharmateelt that W'{, is capable of
`
`being used to 111a]-;e a glucose 1ueasure1ueut, and that Wulafia is suggestive ef this
`11
`
`use 1'11 stating that W9 eau serve as a eetutter electrode and eau be used in
`
`111easure111e11ts relative to reference electrode R. See Ex. 1005. 6: 1-10.
`
`
`
`Winarta
`Ex. 1005
`
`Dr. Smith (Ex. 2008,
`¶¶ 50-53):
`
`“Winarta does not disclose a
`second working sensor
`part/electrode for measuring
`a substance.”
`
`“Winarta suggests using W0 as
`a counter electrode, to
`measure resistance, or as a
`trigger; …”
`
`“Winarta suggests using W0 to
`measure sample resistance,
`not as a second working
`electrode.”
`
`Col. 5-6
`
`12
`
`
`
`United States Patent
`
`[191
`
`Schulman et al,
`
`USU0579 1344!;
`
`[11]
`
`Patent Number:
`
`5,791,344
`
`[451 Date 0f Patent:
`
`"'Aug. 11, 1993
`
`[54] PATIENT MONITORING SYSTEM
`
`Invent0re: Jneeph H. Sehulman. Santa Clarita;
`Ronald J. Lebel. Sherman Oaks:
`Juseph Y. LuI:isIn0. San Diego; Alfred
`E. Mann. Beverly Hills; Orville Rey
`Rule, 111: David I. 'WIIil1:n0:rer. belt of
`L03 Ange-les, all 0!‘ Calif.
`
`[73] Assignee: Alfred E. Mann FOIInflati0n f0r
`Scientific Research. Sylmar. Calif.
`
`[*] Notice:
`
`The term of this patent shall I101: extend
`bejmnd the expiration date 0f Pat. N0.
`5.497.T}'2.
`
`4,332,707
`4,371,331
`4,300,620
`4,331,104
`4,034,330
`
`4.94-4.299
`4,954,129
`3,030,333
`3,133,003
`SJ 90,041
`5.2':'1 £15
`5,32fl,lII'E|ll
`3,322,033
`
`3,496,433
`
`5.41939
`1{l.r’19fi9
`1.-‘[990
`l."l9‘9lJ
`H1990
`
`"H1990
`931990
`‘H1991
`
`BJ'l99’Z
`311993
`131993
`E1994
`E1994
`
`3.c‘1995
`
`...................... 2044415
`Vadgama et al.
`Feinguld ................................
`I5D4II515
`Guugh ................................. 1233635
`Llslfllil at al.
`........................... 2D4a‘4l5
`Maxwell
`1253637
`
`Sjlvian
`Guiliani et al.
`
`........................,.
`
`123:4]?
`I50-I.-’33
`
`............................... 128.-‘I535
`Clarke, Jr.
`Snuma ................................ 128.f68D
`n..¢.u_..........n. an
`Palti
`fifl-I4'fil5
`
`........................... 200413
`Wang .......
`Davidson ...............................
`IZBIQDG
`Allen 01. ill.
`........................... 2lM.r'4l2
`UEDDXEEH at 01
`20-IIJ'4l5
`
`Prinaczrjr Emm£ner—R0bcrt L. Nasser
`Attorney: Agent, 00' F'1'rm--Fitch. Even. Tabin & Flanncsry
`
`13
`
`EX. 1007
`
`Ex. 1007
`
`
`
`Schulman
`
`Schulman
`
`14
`
`
`
`1. A ntethnd efmeasuring the eeneentratien air" a suhstanee
`in a sample liquid eentprisiag the steps nf:
`prtwidin a measnrin devitte said device enm risin:
`
`-
`
`- d::.~wnstrean1 frnln said
`
`in the sample liquid wherein said first and
`.
`-
`seeend waridng seaser parts are ananged sneh that.
`in the ahsenee nf an emar eenditinn, the quantity {if
`said eharge carriers generated by said first wnrking
`sEnsdrs'-pan-are.subat‘antiall}F identical tn the quantity
`ef said charge ear-rieta generated by said seeensi
`working sensar part: and
`15
`
`
`
`Schulman
`“glucose sensor”
`
`Ex. 1007
`
`16
`
`
`
`Schulman
`“glucose sensor”
`
`Ex. 1007
`
`17
`
`
`
`Schulman
`“glucose sensor”
`
`Dr. Smith: “[T]he only use disclosed in Schulman for the W2
`electrode is to measure background oxygen. The W2 electrode
`does not generate charge carriers proportional to the
`concentration of glucose in a sample.” Ex. 2008, ¶63.
`
`18
`
`
`
`Dr. Smith: “Because Schulman uses two completely separate
`electrode systems for any duplicate measurement, each of the
`measurements is made with a separate reference electrode,
`rather than the ‘common reference’ of the ‘105 Patent.” Ex.
`2008, ¶74.
`
`Pharmatech: “LifeScan is correct; the working electrodes in the
`‘105 Patent share the same reference electrode while each
`glucose sensor assembly in Schulman includes its own reference
`electrode.” Paper No. 17 at 7.
`
`19
`
`
`
`Reasons Why No Motivation to
`Combine
`
`20
`
`
`
`Schulman v. ‘105 Patent
`Dr. Smith: ‘[W]hile both the ‘105 Patent and Schulman
`are broadly concerned with the measurement of
`glucose and both use glucose oxidase, the statement
`that they are both based on “GOx mediated electrical
`current is incorrect. … Every current disclosed by
`Schulman as being measured is due to the reduction
`of oxygen, not the reaction between GOx and gluose
`with subsequent oxidation of a mediator as disclosed
`in the ‘105 Patent. Schulman states this explicitly,
`stating ‘oxygen is consumed at the working
`electrode.’” Ex. 2008 ¶68.
`
`21
`
`
`
`Schulman v. ‘105 Patent
`
`Pharmatech: “While both Schulman and the
`‘105 Patent measure electric current to
`determine glucose levels, LifeScan is correct that
`the methodologies differ.” Paper No. 17 at 6.
`
`22
`
`
`
`Schulman
`
`‘105 Patent
`
`23
`
`
`
`Secondary Considerations
`
`24
`
`
`
`Advanced Display Systems, Inc. v. Kent
`State University, 212 F.3d 1272, 1285 (Fed.
`Cir. 2000)
`
`“Zhou's deposition also provides compelling evidence
`of nonobviousness by illustrating ADS's wholesale
`copying of the claimed invention. See Specialty
`Composites v. Cabot Corp., 845 F.2d 981, 991, 6
`U.S.P.Q.2D (BNA) 1601, 1608 (Fed. Cir. 1988)
`(reasoning that an accused infringer's close copying of
`the ‘claimed invention, rather than one in the public
`domain, is indicative of nonobviousness’).”
`
`25
`
`
`
`“I have examined the Pharmatech
`GenStrip test strips, and it is
`apparent that they are copies of the
`test strips illustrated and described
`in the ‘105 Patent (as well as of
`LifeScan’s commercial blood glucose
`test strips which embody the ‘105
`Patent invention.” … I have
`confirmed that these meters
`[LifeScan Ultra meters] when used
`with the LifeScan or Pharmatech
`test strips, carry out [the measuring,
`comparing, giving an error
`indication] steps recited in the ‘105
`Patent claims.”
`Ex. 2008 John Smith Decl. ¶¶91-97
`
`26
`
`
`
`Collateral Estoppel
`
`• Finality of judgment
`• Identity of issue
`
`27
`
`
`
`Federal Circuit Decision
`
`Ex. 1029 at p. 10-11
`
`28
`
`
`
`Federal Circuit Decision
`
`Ex. 1029 at p. 11
`
`29
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent
`
`Owner’s Demonstrative Exhibits was served on counsel of record on May 12,
`
`2014, by filing this document through the Patent Review Processing System, as
`
`well as delivering a copy via overnight mail to the counsel of record for the
`
`Petitioner at the following address:
`
`Patent Docketing
`Lathrop & Gage LLP
`2345 Grand Boulevard, Suite 2800
`Kansas City, MO 64108
`
`
`
`
`
`
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`Date: May 12, 2014